BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 23892412 · Received December 25, 2025

    Report

    Report Number
    3013886523-2025-00335
    Event Type
    Injury
    Date Received
    December 25, 2025
    Date of Event
    December 1, 2025
    Report Date
    January 22, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518839
    PMA / PMN Number
    K944222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H11. THE CATHETER (ID 823045) WAS NOT RETURNED FOR EVALUATION (IS NOT AVAILABLE FOR RETURN AS PER CUSTOMER) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM PERITONEAL CATHETER (ID 823045) WAS IMPLANTED WITHIN VESSELS TO THE PATIENT VIA A VENTRICULOATRIAL (VA) SHUNT ON (B)(6) 2025 DUE TO SECONDARY NORMAL PRESSURE HYDROCEPHALUS. THE DOCTOR REQUESTED TO PUT TOGETHER THE ITEMS TO PERFORM THE VA SHUNT. ON (B)(6) 2025, THE SALES REPRESENTATIVE PREPARED THE SHEATH BY COVIDIEN (B)(6). EVEN THOUGH THIS PRODUCT WOULD NOT FIT INTO THE SHEATH. THE DOCTOR CHANGED THE SHEATH TO 9FR AND MADE BIGGER INCISION WHICH COULD HAVE BEEN AVOIDED. THERE WAS MORE THAN 30 MINUTES OF SURGICAL DELAY. THE SURGICAL DELAY IS NOT DUE TO THE VALVE MALFUNCTION; IT IS BECAUSE THE DOCTOR NEEDED TO PREPARE AND CHANGE THE SHEATH SINCE THE SHEATH WHICH WAS PREPARED BY OUR SALES REP COULD NOT BE USED. THE PATIENT IS IN FOLLOW UP. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THERE ARE ANY PATIENT CONSEQUENCES DUE TO THE SURGICAL DELAY. IT IS ALSO UNKNOWN IF ADDITIONAL ANESTHESIA WAS REQUIRED.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260725 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780518839

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Other